Bacterial vaginosis (BV) is a common condition affecting millions of women annually that is associated with serious health problems such as preterm labor resulting in low birth weight, pelvic inflammatory disease, and increased risk of human immunodeficiency virus infection. See, e.g., Bodner-Adler et al., Am. J. Obstet. Gynecol. 189:139-47, 2003; Hillier et al., Clin. Infect. Dis. 20:Suppl 2:S276-S278, 1995; Peipert et al., Am. J. Obstet. Gynecol. 184:856-63, 2001; Hillier et al., Am. J. Osbstet. Gynecol. 175:435-41, 1996; Martin et al., J. Infect. Dis. 180:1863-1868, 1999; Sturm-Ramirez et al., J. Infect. Dis. 182:467-473, 2000. No single etiologic agent has been implicated as the cause of bacterial vaginosis, and the syndrome is currently considered to be a polymicrobial disorder that is characterized by depletion of vaginal Lactobacillus species that produce hydrogen peroxide and an increase in the quantity of several vaginal anaerobic bacteria. See, e.g., Eschenbach et al., J. Clin. Microbiol. 27:251-256, 1989; Fredricks et al., J. Clin. Microbiol. 47:721-726, 2009.
The more recent use of cultivation-independent analyses of 16S rRNA gene sequences has identified various, previously unrecognized species that are prevalent in the vaginal flora and appear to be associated with BV. See, e.g., Fredricks et al., N. Engl. J. Med. 353:1899-1911, 2005; Ferris et al., J. Clin. Microbiol. 45:1016-1018, 2007. Among these species are Gardnerella vaginalis. See, e.g., Fredricks et al., supra. Recent studies also suggest that Gardnerella vaginalis plays an important role in BV pathogenesis and may be a suitable marker of disease and treatment response. See Fredricks et al., J. Clin. Microbiol. 47:721-726, 2009.
Accordingly, there is a need for compositions, kits, and methods for rapidly and accurately detecting the presence or abundance of Gardnerella vaginalis in a specimen. Such compositions, kits, and methods would be particularly useful for the diagnosis of BV or for monitoring a patient's response to BV treatment. The present invention meets these and other needs.